CTRI Number |
CTRI/2021/12/038798 [Registered on: 21/12/2021] Trial Registered Prospectively |
Last Modified On: |
09/12/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
COMPARATIVE STUDY OF HAEMORRHOIDAL SUPPOSITORY FROM MODERN AND AYURVEDIC VIEW |
Scientific Title of Study
|
Randomized control clinical study to evaluate the efficacy of Arshoghnivarti and Corect Suppository in Hemorrhoids. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Sandeep Tanaji Nikam |
Designation |
Assistant Professor |
Affiliation |
PDEAs College of Ayurveda and research centre |
Address |
Dr M.N. Agashe charitable hospital ( Aryangla Hospital), 6 SHUKRUVAR PETH, Department of shalya,first floor, opd no 2. SECTOR 27, PRADHIKARAN, NIGDI, PIMPRI CHINCHWAD, MAHARASHTRA.
department of shalya,Ground floor, opd 123 Pune MAHARASHTRA 415002 India |
Phone |
09850487568 |
Fax |
- |
Email |
drsandeepnikam.ms@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
madhavi sanjay banarase |
Designation |
Professor |
Affiliation |
PDEAs College of Ayurveda and research centre |
Address |
SECTOR 27, PRADHIKARAN, NIGDI, PIMPRI CHINCHWAD, MAHARASHTRA.
department of shalya, ground floor ,opd 123. SECTOR 27, PRADHIKARAN, NIGDI, PIMPRI CHINCHWAD, MAHARASHTRA.
department of shalya, ground floor ,opd 123. Pune MAHARASHTRA 411044 India |
Phone |
9423207569 |
Fax |
- |
Email |
dr.madhavibanarase209@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Sandeep Tanaji Nikam |
Designation |
Assistant Professor |
Affiliation |
PDEAs College of Ayurveda and research centre |
Address |
Dr M.N. Agashe charitable hospital ( Aryangla Hospital), 6 SHUKRUVAR PETH. department of shalya,first floor, opd 2 SECTOR 27, PRADHIKARAN, NIGDI, PIMPRI CHINCHWAD, MAHARASHTRA. department of shalya,ground floor ,opd 123. Pune MAHARASHTRA 415002 India |
Phone |
09850487568 |
Fax |
- |
Email |
drsandeepnikam.ms@gmail.com |
|
Source of Monetary or Material Support
|
ARYANGLA HOSPITAL, 6 SHUKRUVAR PETH, SATARA 415001 |
PDEAS COLLEGE OF AYTURVD AND RESEARCH CENTRE, AKURDI , PUNE 411044 |
|
Primary Sponsor
|
Name |
SANDEEP TANAJI NIKAM |
Address |
PDEAS CARC COLLEGE OF AYURVED AND RESEARCH CENTRE, PUNE-411044 |
Type of Sponsor |
Other [self] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
DR SANDEEP NIKAM |
ARYANGLA HOSPITAL |
Dr M.N. Agashe charitable hospital ( Aryangla Hospital), 6 SHUKRUVAR PETH,satara.department of shalya,first floor. opd 2 Satara MAHARASHTRA |
9850487568
drsandeepnikam.ms@gmail.com |
DR MADHAVI BANARASE |
PDEAS COLLEGE OF AYURVED AND RESEARCH CENTRE AKURDI |
PRADHIKARAN NIGDI NEAR VITTLE RUKMAYI TEMPLE, AKURDI
PUNE 411044.department of shalya,ground floor. opd 123 Pune MAHARASHTRA |
9423207569
dr.madhavibanarase209@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
PZETs college of Ayurved and research centre,akurdi pune |
Approved |
SCM AVM SATARA |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:K642||Third degree hemorrhoids. Ayurveda Condition: ARSAH, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
ARSHOGHNIVARTI |
ONE SUPPOSITARY PER RECTAL TWICE A DAY GHUTA LUBRICATION FOR 15 DAYS |
Comparator Agent |
CORECT SUPPOSITARY |
ONE SUPPOSITARY PER RECTAL TWICE A DAY FOR 15 DAYS |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
PATIENTS DIAGNOSED WITH FIRST, SECOND AND THIRD DEGREE OF HEMORRHOIDES. |
|
ExclusionCriteria |
Details |
PATIENTS WITH 4TH DEGREE OF HEMORRHOIDES.
KNOWN CASE OF D.M,HTN,LIVER DISEASES OR MALIGNANCY.
PATIENTS DIAGNOSED WITH FISSURTE IN ANO.
PATIENT WITH CA RECTUM.
PREGNANT AND LACTATING WOMAN.
PATIENT WITH HEMOGLOBIN BELOW 8 GM. |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate the efficacy of Arshoghnivarti against Corect suppository in Hemorrhoids. |
15 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
To study adverse effects of Arshoghnivarti and of Corect suppository if any. |
15 days |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
|
01/01/2022 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - drsandeepnikam.ms@gmail.com
- For how long will this data be available start date provided 31-12-2023 and end date provided 01-01-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
TITLE- A
RANDOMIZED CONTROL CLINICAL STUDY TO EVALUATE THE EFFICACY OF ARSHOGHNIVARTI
AND CORECT SUPPOSITORY IN HEMORRHOIDS.
Research Question :-
Is Arshoghnivarti more effective than Corect
suppository in hemorrhoids.
Hypothesis –
Arshoghnivarti is more
effective than Corect suppository in hemorrhoids.
NullHypothesis
(Ho) :-Arshoghanivarti is as effective as Corect suppository in hemorrhoids.
Alternate Hypothesis
(H1) :-Arshoghnivarti is more
effective than Corect suppository in hemorrhoids.
(H2) : - Arshoghnivarti is less effective than Corect suppository in hemorrhoids.
Rationale:-
1) Nowadays fast foods,
sedentary lifestyles, irregularity in meals etc. have lead to impairment of
gastrointestinal system. This has lead to an increase in diseases of the
gastrointestinal tract. One of the major groups of these diseases are the
ano-rectal diseases.
2)According to Indian
journal of surgery the incidence of hemorrhoids is 72% and prevalence rate 38.93%
As far as the treatment of hemorrhoids is concerned use of laxatives and
surgical therapy is by far the choice of treatment in modern medicine. Surgery
is costly and post operative morbidity is frequently seen.
3)Ayurveda offers enteral
as well as local therapies for Arsha. In addition to this various surgical and
para surgical procedures are also mentioned. A lot of work has been done on
arsha. But local drug therapy, its action on local anal mucosa needs
exploration. One such refrence is mentioned in BhaishajyaRatnawali.
This reference of Arshoghnivartiseems like an effective
local treatment option in hemorrhoids. Ghoshatak or koshataki is ruksha, katu,
pachan as well as virechak. This gunas of koshataki may help in the
sampraptibhanga of arsha disease2. Also it is mentioned as a drug
which can be used in Arsha in the Nighantus.
Keeping this in mind this study is planned. Drug review – A) Trial drug=- Arshoghnivarti (Suppository) Contents -1 Ghoshatak (Luffaactuangula var.) Guda (Jaggery) – as a binding agent. Drugs will be procured from authentic sources. Authentication and
standardization will be done.
Final product will be standardized. B) Control Drug- Corect suppository-merd meridian labs Contents- Allantoin-0.5% w/w Hydrocortisone – 0.25% w/w Lidocain -3% w/w
Zinc oxide-5% w/w
AIM AND OBJECTIVES:- Aim:- To evaluate and compare the efficacy of Arshoghnivarti and Corect suppository on hemorrhoids. Objectives:- Primary objective - To evaluate the efficacy of Arshoghnivarti against
Corect suppository in Hemorrhoids. Secondary objective -
To study adverse effects of Arshoghnivarti and of
Corect suppository if any. Materials and Methodology – Materials - 1. Patients : Selection Of patients – Patients diagnosed with hemorrhoids fulfilling the inclusion criteria’s
will be selected from subjects coming in the Out patient Department (OPD) and
patients admitted in the in patient department (IPD) of the Ayurvedic hospital. This study is aimed at completing 100 patients. 2. Drug – Drug will be standardized. Methods of
Standardization: A) Raw material - As per
Pharmacopeial(API) guidelines: B) IPQC (In process quality control) – As per
GMP:
C)Finished product
standardization – As per Pharmacopeia Guidelines. Diagnostic criteria of patients :- 1)Signs and symptoms of hemorrhoids. 2)Per Rectal examination
3) Proctoscopy GROUPING OF PATIENTS-
|
GROUP A
|
GROUP B
|
Drug
|
Arshoghnivarti(suppository) along with
concomitant oral treatment and dietetic advice.
|
Corect suppository
along with concomitant oral treatment
and dietetic advice.
|
Dosage
|
1 suppository per rectally twice a day.
suppository will be inserted by lubricating with Ghruta.
|
1 suppository per rectally twice a day.
|
Route of administration
|
Per rectal
|
Per rectal
|
Duration
|
15 days
|
15 days
|
Study design -
Prospective randomized control clinicalstudy
Screening of patients for diagnosis and inclusion
Initial assessment
Randomization (lottery method)andGroupallocation
1.Group A :(50Patients)-
Arshoghnivarti (suppository) per rectally twice a day for 15 days.
|
|
2. Group B:(50Patients)-
Corect suppository per rectally twice a day for 15 days.
|
Follow up on day 7 of treatment and on completion of treatment 15th
day will be taken.
Observations
Statisticalanalysis
Conclusion Duration
of study– 15 days
Sample size – According to statistics n = 100.
n =Z2pq/e2
z- constant= 1.96
p= prevanlace9=
38.93%-
q=1-p
e= standard error= 10-15%
Considering a drop out of
30% minimum 130 patients will be enrolled in the study. This study is aimed at
completing 100 patients.
Data collection methods –
A case record form is prepared for detailed data collection. Data will be
collected according to the case proforma.
Consent – Informed written
Consent will be obtained prior to the trial from each patient. CRI
TERIA FOR ASSESSMENT
SubjectiveParameters:-
1)
Bleeding per rectum
2)
Pruritisani
3)
Pain
4)
Tone of anal sphincter.
ObjectiveParameter8:-
Degree of Hemorrhoids
SUBJECTIVEPARAMETER GRADATION:-
1.
P/R
bleeding Grade –
1st grade – 0- 5 drops.
2nd grade – 6 – 15 drops.
3rd grade – more than 15 drops.
2.
Pain
–
will be assessed using VAS scale with 0 - 10
score.
3.
PruritisAni
–
will be assessed using VAS scale with 0 - 10 score
4. Tone of anal sphincter-
DRESS ( Digital Rectal Examination scoring System)10- 0-5
0- No discernable pressure
3- normal tone
5- Extremely tight sphincter
OBJECTIVEPARAMETERGRADATION –
Degree of Hemorrhoids –
1st degree Hemorrhoids- Hemorrhoids projecting slightly in the lumen
of anal canal, no prolapse.
2nd degree Hemorrhoids– Hemorrhoids
prolapse out of he anus while defecation but return spontaneously to the anal
canal when defecation ceases.
3rd degreeHemorrhoids– Hemorrhoids
prolapse out of he anus while defecation but return manually to the anal.
STATISTICAL ANALYSIS
All observed data collected after the final
assessment will be subjected to suitable statistical analysis. The Quantitative
data will be analyzed by Statistical Z test and t test paired for within the
groups and unpaired for between the groups for overall benefits. Qualitative
data will be analyzed with Wilkosons test.
DISCUSSION:
The observed results in both the groups will
be compared and the differences and effects will be discussed. Adverse effects
if any observed will be discussed.
CONCLUSION:-
Conclusion will be drawn based on overall
assessment, tabulation, statistics and graphic presentation of the data.
SUMMARY-
The comparative clinical study will be
summarized in brief after completion of the study.
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